Methods and Devices for Electrosurgery

ABSTRACT

Devices and methods for electrolytic electrosurgery wherein a detector is located proximal to an active electrode on an electrosurgical probe, optionally disposed between the active electrode and a return electrode, the detector detecting at least on parameter relating to electrolysis. The detected parameter can include pH concentration, conductivity, impedance, ion, concentration, electrolytic gas consumption, electrolytic gas production, pressure or sound. The detected parameter can be employed in control systems to control systems to control activation or operation of the electrosurgical probe.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent Ser. No. 12/778,036,entitled Devices for Electrosurgery, filed on May 11, 2010, which is acontinuation of U.S. patent Ser. No. 12/239,320, entitled Devices forElectrosurgery, filed on Sep. 26, 2008, and Issued as U.S. Pat. No.7,713,269 on May 11, 2010, which itself is a divisional application ofU.S. patent Ser. No. 11/061,397, entitled Devices for Electrosurgery,filed on Feb. 17, 2005 and Issued as U.S. Pat. No. 7,245,619 on Nov. 4,2008, which itself is a continuation-in-part application of U.S. patentapplication Ser. No. 10/486,739, entitled Methods and Devices forElectrosurgery, filed on Aug. 24, 2004, which in turn was a nationalstage entry pursuant to 35 U.S.C. §371 of International ApplicationSerial No. PCT/US02/26277, entitled Methods and Devices forElectrosurgery, filed on Aug. 15, 2002, which claimed the benefit ofU.S. Provisional Patent Application Ser. No. 60/312,965, entitled Systemand Method of Electrosurgical Biologic Tissue Modification and TreatmentUtilizing Oxy-Hydro Combustion—Acid Base Shift Reactions, filed on Aug.15, 2001. The 12/778,036 application is also a continuation-in-partapplication of U.S. application Ser. No. 10/119,671, entitled Methodsand Devices for Electrosurgery, filed on Apr. 9, 2002, issued as U.S.Pat. No. 6,902,564 on Jun. 7, 2005, which claimed priority to U.S.Provisional Application Ser. No. 60/312,965, entitled System and Methodof Electrosurgical Biologic Tissue Modification and Treatment UtilizingOxy-Hydro Combustion—Acid Base Shift Reactions, filed on Aug. 15, 2001.The 12/778,036 application is a continuation-in-part application of U.S.application Ser. No. 11/010,174, entitled Methods for ElectrosurgicalElectrolysis, filed on Dec. 10, 2004, issued as U.S. Pat. No. 7,819,861on Oct. 26, 2010, which in turn is a continuation application ofInternational Application Serial No. PCT/US03/18575, entitled Methodsand Devices for Electrosurgical Electrolysis, filed on Jun. 10, 2003,which claimed priority to U.S. Provisional Patent Application Ser. No.60/387,775, entitled Methods and Devices for ElectrosurgicalElectrolysis, filed on Jun. 10, 2002. The 12/778,036 application is alsoa continuation-in-part application of U.S. application Ser. No.10/414,781, entitled Method For Achieving Tissue Changes In Bone OrBone-Derived Tissue, filed on Apr. 15, 2003, issued as U.S. Pat. No.7,105,011 on Sep. 12, 2006, which in turn was a divisional applicationof U.S. Pat. No. 6,547,794, entitled Methods for Fusing Bone DuringEndoscopy Procedures, issued on Apr. 15, 2003, and filed as U.S. Ser.No. 09/885,749 on Jun. 19, 2001, which claimed priority to U.S.Provisional Patent Application Ser. No. 60/226,370, entitled Method ForFusing Bone During Endoscopy Procedures, filed on Aug. 18, 2000, and ofU.S. Provisional Patent Application Ser. No. 60/272,955, entitled MethodFor Fusing Bone During Endoscopy Procedures, filed on Mar. 2, 2001. The12/778,036 application is also a continuation-in-part application ofU.S. application Ser. No. 10/741,753, entitled Methods and Compositionsfor Fusing Bone During Endoscopy Procedures, filed on Dec. 19, 2003,which in turn was a continuation application of InternationalApplication No. PCT/US02/19498, International Publication WO 02/102438,entitled Methods and Compositions For Fusing Bone During EndoscopyProcedures, filed on Jun. 19, 2002, which in turn was acontinuation-in-part application of U.S. Pat. No. 6,547,794, entitledMethods for Fusing Bone During Endoscopy Procedures, issued on Apr. 15,2003, and filed as U.S. Ser. No. 09/885,749 on Jun. 19, 2001, whichclaimed priority to U.S. Provisional Patent Application Ser. No.60/226,370, entitled Method For Fusing Bone During Endoscopy Procedures,filed on Aug. 18, 2000, and of U.S. Provisional Patent Application Ser.No. 60/272,955, entitled Method For Fusing Bone During EndoscopyProcedures, filed on Mar. 2, 2001. The 12/778,036 applications claimsthe benefit of the filing of U.S. Provisional Patent Application Ser.No. 60/545,097, entitled Devices for Electrosurgery, filed on Feb. 17,2004. The specification of each is incorporated herein by reference.This application is a divisional application of U.S. Ser. No. 11/006,079filed Dec. 6, 2004 and issued as U.S. Pat. No. 7,771,422 on Aug. 10,2010, which is a continuation-in-part application of InternationalApplication No. PCT/US03/18116, International Publication WO 03/103521,entitled “Methods and Devices for Electrosurgery”, filed on Jun. 6, 2003which claims the benefit of the filing of U.S. Provisional PatentApplication Ser. No. 60/387,114, entitled Methods and Devices forElectrosurgery, filed on Jun. 6, 2002, and of U.S. Provisional PatentApplication Ser. No. 60/387,775, entitled Methods and Devices forElectrosurgical Electrolysis, filed on Jun. 10, 2002. The specificationof each of the foregoing is incorporated herein by reference.

The subject of U.S. Ser. No. 11/010,174 filed Dec. 10, 2004 and issuedas U.S. Pat. No. 7,819,861 on Oct. 20, 2010 is a continuation-in-part ofU.S. patent application Ser. No. 11/006,079 filed Dec. 6, 2004 andissued as U.S. Pat. No. 7,771,422 on Aug. 10, 2010, and is acontinuation-in-part of U.S. patent application Ser. No. 10/119,671,entitled Methods and Devices for Electrosurgery, to Morgan, et al.,filed on Apr. 9, 2002, and a continuation-in-part to U.S. patentapplication Ser. No. 10/157,651, entitled Biologically EnhancedIrrigants, to Morgan, et al., filed on May 28, 2002 and thespecifications thereof are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention (Technical Field)

The present invention relates to methods and devices for electrosurgery,including devices that operate in an electrolyzable media, including anaqueous electrolyzable media, by means of electrolysis and oxy-hydrogencombustion, and such devices with sensors and detectors for electrolysisand oxy-hydrogen combustion-specific parameters.

2. Description of Related Art

Note that the following discussion refers to a number of publications byauthor(s) and year of publication, and that due to recent publicationdates certain publications are not to be considered as prior artvis-à-vis the present invention. Discussion of such publications hereinis given for more complete background and is not to be construed as anadmission that such publications are prior art for patentabilitydetermination purposes.

Electrosurgical devices have become widely popular for use in manymedical treatment settings. However, limits in the ability to detect andmeasure the relevant parameters of the electrosurgical process have beenknown to impair the practitioner's ability to accurately andcontemporaneously alter the electrosurgical application procedure toguard against treatment sequelae, induced iatrogenic damage, or tohinder the attainment of attaining treatment goals.

Although the need for such detection and measuring devices has beenrecently recognized, prior art contemplation and/or development of suchdevices has been limited to electrosurgical bulk property measurementssuch as temperature, fluid field impedance, and fluid field capacitance.This limitation has been due to both the inherent constraints indeveloping sensing and measuring devices within the foundation of thephysiochemical paradigm of electrosurgery disclosed in the prior art,and to the perceived importance of such bulk property measurement fordetermining the extent and effect of electrosurgery.

As disclosed in U.S. patent application Ser. No. 10/119,671,electrosurgery has been incorrectly construed as being governed byplasma formation or related forms of ionization (see, e.g., U.S. Pat.Nos. 5,669,904, 6,206,878, 6,213,999, 6,135,998, 5,683,366, 5,697,882,6,149,620, 6,241,723, 6,264,652, 6,322,549, 6,306,134 and 6,293,942, andthe like), and this misconception has led to limited contemplation anddevelopment of detection and measuring devices for use duringelectrosurgical therapeutic applications. For example, in the plasmaphysiochemical paradigm of electrosurgery, it would be anticipated thatdetection and measuring devices would be contemplated and/or developedthat require the use of instruments that can detect and measure the highenergy emissions of plasma formation. Such emissions would includeradiation elements such as free electrons, alpha particles, gammaparticles, and x-rays. This approach has not been implemented, despiteclaims in the prior art that sufficient radiation signal intensity bymeans of a plasma is generated by the electrosurgical process, relativeto normal background levels of radiation noise, necessary for treatmentprotocols and therapeutic effects. If sufficient radiation signalintensity is demonstrated, it would follow that useful detection andmeasuring devices could be developed with sensing and measuringalgorithms for correlating these radiation measurements to treatmenteffects. However, this endeavor would require multivariate responsesurface modeling. Because modeling correlates currently exist only forhighly idealized plasma generating environments utilizing vacuumchambers and/or magnetic field control, such detection and measuringdevices have not been pursued. Extrapolating such ideal conditions tothe in vivo application of electrosurgery methods and devices wouldprove insurmountable. For this reason, no further development of sensingand measuring devices of the electrosurgical process have been developedother than that of bulk property measurements; thus, plasma-relatedelectrosurgical physiochemical paradigms have constrained theconceptualization and development of sensing and measuring devices forelectrosurgery to those of the bulk property measurements as disclosedin prior art.

The perceived importance of bulk property measurement for determiningthe extent and effect of electrosurgery has been well documented.Quantifying energy input indirectly through temperature measurement,fluid field impedance measurement, and fluid field capacitancemeasurement is believed to indicated the degree to which electrosurgerywill effect tissue and the host response thereof. Since suchcorrelations have been extremely inconsistent in practice, a significantamount of confusion has surfaced regarding therapeutic electrosurgicalprotocols, often leading to the reduction in use of electrosurgicaldevices for certain applications. See, e.g., Thermometric determinationof cartilage matrix temperatures during thermal chondroplasty:comparison of bipolar and monopolar radiofrequency devices. Arthroscopy,2002 April; 18(4):339-46. The reliance upon bulk property measurementsin developing therapeutic protocols incompletely addresses the truephysiochemical processes of electrosurgery based upon the more detailedunderstanding of electrosurgery processes and phenomena describedherein.

In the prior art, for example, temperature sensing devices have beendisclosed that allow feedback measurement of the treatment environmenttemperature, such as referenced in U.S. Pat. Nos. 6,162,217, 5,122,137and U.S. Published Patent Application 2001/0029369, and the like. Thesemethods have been determined to be inaccurate due to the typically rapidchanging milieu of the treatment locale. See, e.g., Radiofrequencyenergy-induced heating of bovine articular cartilage using a bipolarradiofrequency electrode. Am J Sports Med, 2000 September-October;28(5):720-4. These devices do not accurately capture themultidimensional physiochemical occurrences of electrosurgerycontemporaneously.

Further, fluid field impedance and fluid field capacitance sensingdevices have been disclosed in prior art that allow feedback control ofgenerator power output that drives the electrosurgical process, such asreferenced in U.S. Pat. Nos. 6,306,134, 6,293,942, and the like. Energydelivery control is limited to these bulk properties which have yet tobe accurately or completely correlated to the physiochemical governingrelations of electrosurgery, and has proved to be too inaccuraterelative to tissue response to serve as therapeutic benchmarking orcontrolling parameters.

However, as disclosed in U.S. patent application Ser. No. 10/119,671,the electrosurgical process is governed not by plasma or related formsof ionization but by electrolysis and oxy-hydro combustion. Therefore,development of electrosurgical devices and methods that are tailored todetect and measure the relevant parameters of electrolysis and oxy-hydrocombustion are more appropriate and needed to enable desired treatmentoutcome. Clearly, there is a need for electrosurgical devices that arenot only optimized to the true physical and chemical processes involvedin the operation and use of such electrosurgical devices upon biologictissue within safe energy spectra and power ranges, but also the needfor the sensing and measurement of the true physiochemical occurrencesof electrosurgery. Such devices will allow the more accurate and safeapplication of electromagnetic energy for electrosurgery to achieveintended outcomes.

Disclosed herein are two distinct means to accomplish these goals, whichhave heretofore not been contemplated or accomplished due to the lack ofrecognition of the electrolysis and oxy-hydro combustion process asinherent in electrosurgery: (1) the real-time simultaneous andcontemporaneous detection and measurement of the relevant parameters ofelectrosurgery as described in the electrolysis and oxy-hydro combustionphenomena and (2) the placement of these detection and measurementdevices within the surgical instrumentation itself, geographicallyjuxtaposing sensing and measuring devices with treatment deliverydevices, allowing for direct feedback of the treatment site to themedical practitioner.

BRIEF SUMMARY OF THE INVENTION

In one embodiment the invention provides an electrosurgical probe forperforming electrosurgery, which probe includes an active electrode anda return electrode separated by an insulating member and means forsensing and transducing pH concentrations in proximity to the activeelectrode and return electrode. The means for sensing and transducing pHconcentrations can include a miniature glass bulb and Ag—Cl sensing wireprobe. The electrosurgical probe of the invention can further include anelectrosurgical controller that incorporates the pH signal in controlalgorithms to meter power output to the active electrode.

In another embodiment the invention provides an electrosurgical probefor performing electrosurgery, which probe includes an elongated memberwith an active electrode and a return electrode separated by aninsulating member at the distal end of such elongated member, with athermo-luminescent crystal generating a temperature signal positionedadjacent to the active electrode. The thermo-luminescent crystal caninclude a beacon insert within a larger insulating member. Thethermo-luminescent crystal can be positioned so as to be immediatelyadjacent the active electrode. The electrosurgical probe can furtherinclude an electrosurgical controller that incorporates the temperaturesignal generated by the thermo-luminescent crystal in control algorithmsto meter power output to the active electrode.

In yet another embodiment the invention provides an electrosurgicalprobe for performing electrosurgery, which probe includes an activeelectrode and a return electrode separated by an insulating member, anda conductivity metering device that generates a conductivity signal. Theconductivity metering structure can be located adjacent to the activeelectrode. The electrosurgical probe can further include anelectrosurgical controller that incorporates the conductivity signal incontrol algorithms to meter power output to the active electrode.

In yet another embodiment the invention provides an electrosurgicalprobe for performing electrosurgery, which probe includes an activeelectrode and a return electrode separated by an insulating member andan acoustic detector device that generates an acoustic signal, therebydetecting the electrolysis phenomena and rate. The electrosurgical probecan further include an electrosurgical controller that incorporates theacoustic signal in control algorithms to meter power output to theactive electrode.

In yet another embodiment the invention provides an electrosurgicalprobe for performing electrosurgery, which probe includes an activeelectrode and a return electrode separated by an insulating member, andan ion sensor device generating an ion sensor signal. Theelectrosurgical probe can further include an electrosurgical controllerthat incorporates the ion sensor signal in control algorithms to meterpower output to the active electrode.

In yet another embodiment the invention provides an electrosurgicalprobe for performing electrosurgery, which probe includes an activeelectrode and a return electrode separated by an insulating member, anda gas production sensor generating a gas production sensor signal. Theelectrosurgical probe can further include an electrosurgical controllerthat incorporates the gas production sensor signal in control algorithmsto meter power output to the active electrode.

In yet another embodiment the invention provides an electrosurgicalprobe for performing electrosurgery, which probe includes an activeelectrode and a return electrode separated by an insulating member, anda thermo-electric semi-conductor generating a thermo-electric signal.The electrosurgical probe can further include an electrosurgicalcontroller that incorporates the thermo-electric signal in controlalgorithms to meter power output to the active electrode.

In yet another embodiment the invention provides an electrosurgicalprobe for performing electrosurgery, which probe includes an activeelectrode and a return electrode separated by an insulating member, anda piezo-electric thin-film pyrometer generating a piezo-electric signal.The electrosurgical probe can further include an electrosurgicalcontroller that incorporates the piezo-electric sensor signal in controlalgorithms to meter power output to the active electrode.

The invention further provides a method wherein sensing, measuring, anddetecting one or more relevant parameters of electrosurgery isperformed, thereby allowing increased treatment safety, efficacy, andallowing the ability to more effectively utilize either electrolysisand/or oxy hydro combustion reactions and phenomena that occur duringelectrosurgical application, wherein such use of electrolysis and/oroxy-hydro combustion that occurs during electrosurgical application ispart of the treatment protocol.

A primary object of the present invention is to devices and methodsrelating to detection of one or more parameters relevant to electrolyticelectrosurgery.

Another object is to provide detectors or sensors located proximal tothe active electrode of an electrolytic electrosurgery probe.

Another object is to provide detectors or sensors disposed between anactive electrode and a return electrode of an electrolyticelectrosurgery probe.

Another object is to provide detectors or sensors located within acavity or chamber wherein the active electrode of an electrolyticelectrosurgery probe is disposed.

Another object is to provide detectors or sensors located within avariable volume cavity or chamber wherein the active electrode of anelectrolytic electrosurgery probe is disposed.

Yet another object of the invention is to provide detectors or sensorsfor measuring one or more parameters including pH concentration,temperature, conductivity, impedance, ion concentrations, gas productionor sound.

Yet another object of the invention is to provide control systems forcontrolling an electrolytic electrosurgery probe utilizing detectors orsensors determining one or more parameters relevant to electrolyticelectrosurgery.

Other objects, advantages and novel features, and further scope ofapplicability of the present invention will be set forth in part in thedetailed description to follow, taken in conjunction with theaccompanying drawings, and in part will become apparent to those skilledin the art upon examination of the following, or may be learned bypractice of the invention. The objects and advantages of the inventionmay be realized and attained by means of the instrumentalities andcombinations particularly pointed out in the appended claims.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The accompanying drawings, which are incorporated into and form a partof the specification, illustrate one or more embodiments of the presentinvention and, together with the description, serve to explain theprinciples of the invention. The drawings are only for the purpose ofillustrating one or more preferred embodiments of the invention and arenot to be construed as limiting the invention. In the drawings:

FIG. 1A is the stoichiometric chemical equation for chemical reactionsrelated to the invention which govern the electrosurgical process;

FIG. 1B is the equation for and a view of the acid-base “throttle”effect;

FIG. 1C is the equation for and a view of the generalized form of theelectrolysis and oxy-hydro combustion reaction process;

FIG. 1D is the equation for and a view of the generalized form of theelectrolysis and oxy-hydro combustion reaction process showing theeffect of varying molar coefficients;

FIG. 2A is a flowchart for a control logic of the invention provided bythe sensing and control systems and the relevant decision/action pointsfor a thermo-luminescent crystal monitoring system;

FIG. 2B is a flowchart for a control logic of the invention provided bythe sensing and control systems and the relevant decision/action pointsfor a generalized monitoring system;

FIG. 3 is a view of the cross section of a probe of the invention with athermo-luminescent crystal sensing system resident on the distal tip;

FIG. 4 is a view of the cross section of a probe of the invention with apH sensing system resident on the distal tip;

FIG. 5A is a view of an experimental apparatus set-up using anelectrosurgical probe and an ionizing radiation detector;

FIG. 5B is a view of a time integration experiment utilizing x-raysensitive film for 30 minutes;

FIG. 6 is a view of a probe of the invention with a fiber-optic sensingarray for utilizing FTIR, GFCR, and optical pyrometric algorithms andcircuitry for governing electrosurgical processes;

FIGS. 7A and 7B are views of a probe of the invention with aconductivity sensor at the distal tip for sensing acid-base shifts atthe locality of the surgical site;

FIG. 8 is a view of a probe of the invention with a piezo-acousticsensor for detecting oxy-hydro combustion zone sound shift and providinga feedback measurement for governing electrosurgical processes;

FIG. 9 is a view of a probe of the invention utilizing a single wire ionsensor;

FIG. 10 is a view of a probe of the invention utilizingthermo-luminescent crystal material as an insert for athermo-luminescent crystal beacon;

FIG. 11 is a view of a probe of the invention utilizing athermo-electric semi-conductor as a piezo-electric pyrometer;

FIG. 12 is an electrosurgical map which provides the arenas in which themethods and devices disclosed herein may be utilized;

FIG. 13 is generic characteristic curve for a hypothetical impedanceprofile of an established plasma;

FIG. 14 is a generic characteristic curve for the impendance versuspower of a typical immersed electrosurgical probe; and

FIG. 15 is a view of a probe of the invention with an adjustableinsulating cylindrical sleeve and at least one detector.

DETAILED DESCRIPTION OF THE INVENTION

For many years, the etiology of the phenomena observed in medicalprocedures utilizing radio frequency energy sources has beenmisidentified. As an example, in a recent publication, Stalder et al:Repetitive plasma discharges in saline solutions, Applied PhysicsLetters, December 2001, the electrosurgical condition expected during astandard electrosurgery procedure was tested. The authors describephoton emission from a saline solution as the hypothesized result of theformation of free electrons and positively charged ions interactingwithin a thin vapor envelope. Despite their contention andphysiochemical hypothesis, it has become clear that this paradigm isincorrect. It is not possible that this phenomenon, should it exist atall, exists to a level responsible for the effects observed inelectrosurgery. In fact, the contribution of a plasma to the treatmentof organic matter in this instance is negligible as disclosed below. Amore reasonable cause of the phenomena observed during electrosurgicalprocedures and applications, which more clearly fits the observations ofStadler et al, is the result of electrolysis and oxy-hydro combustion,as disclosed in U.S. patent application Ser. No. 10/119,671.

As further clarification of this disclosure, review of the definition ofplasma, a definition that has become well accepted in the scientificcommunity, is relevant. This review demonstrates that as medicalapplications have been developed utilizing radio frequency energy,misconceptions regarding the use of the term “plasma” have surfaced dueto the common and traditional link between radio frequency energy andplasma formation in other settings.

It is no longer necessary to hesitantly state as many early and recenttextbooks did and do that a fourth state of matter exists in theuniverse—referred to as a plasma. Ionizing radiation is ubiquitous inthe universe and is most commonly witnessed as the fusion process instars. The ubiquity of plasma becomes clear when the total abundance ofall elements in the universe is considered as more than 99% of theuniverse's total mass exists within stars. The state of matter found instars is considered to be this fourth state of matter, or plasma.Related to a gas by the general disorder and random distribution ofparticles, a plasma differs from ordinary gases in that its particlesare mostly deficient of an electron, making them positive ions. Innatural stable plasmas like the sun, stability is maintained by theenormous gravitational forces which contain the particles. Theconditions found in stars of high temperatures and gravitational forcesresults in the only non-transient, stable, free natural plasmas known.

Plasmas formed in laboratories and those used for industrialapplications such as metal fabrication are considered metastable, as theequilibrium state of the plasma components at standard pressure andtemperature is one of the more commonly known states of matter, i.e.solid, liquid, or gas.

Without sustained input energy, plasmas normally self-quench and revertto one of these more stable states of matter via several processes. Themost common of these processes is the recombination of a free electronwith an ion dropping the total internal energy of the plasma below itsnormal “activation” energy; in most cases this results in the formationof a gas. A second common scenario is the attraction of the positiveions within the plasma to a negative ground. Positive ions willnaturally flow toward the strong negative potential generated by theearth (lightning provides a commonly known example), similar to theconditions responsible for the movement of charge in electricalcircuits.

As a result of the natural propensity of a plasma to self-quench viathese processes, man-made plasmas must overcome these obstacles. Thisfeat is typically accomplished by the steady input of energy into theplasma to constantly strip electrons from atoms and the confinement ofboth the electron and ion via a magnetic field (preventing the flow toground). Man-made plasma formation is the result of either of twowell-known processes, radio frequency coupling or heating. These twoprocesses are fundamentally different but create the same effect of ionformation and preventative recombination. Plasmas generated by radiofrequency sources use high frequency, high potential electromagneticradiation to strip electrons from the outermost shells of the atoms in agas. The energy coupled to plasma not only creates the ions andelectrons, but also keeps them from recombining. In plasmas generated byhigh temperatures, large electrical currents are passed throughfilaments which results in heating. This heating actually causeselectrons to “boil” off, by means of thermal excitation, the filament.The electrons then interact with the gas surrounding the filament,easily displacing electrons from their respective orbital sites,creating positively charged ions. The high temperature case is theeffect observed in stars (a result of hydrogen-hydrogen fusion intohelium), wherein the temperatures are high enough to both stripelectrons from the gas and keep them from recombining. What becomesevident from observation of man-made plasma in the laboratory orindustrial case is that very high energy must be continuously added tothe system to maintain matter in the plasma state.

Yet another obstacle in the plasma paradigm of electrosurgery is thecontainment of the plasma as to prohibit the loss of charged particlesto a ground plane so that they may be available for therapeutic effects.This containment is ordinarily accomplished by confining the electronsand ions in a magnetic field, so that when plasma is condensed, theefficiency of free electron and gas interaction cascades, therebyconverting yet more gas into plasma. In vacuum conditions, a smallpartial pressure of gas can be excited to form a plasma with just onesingle electron. A single electron yields a cascade effect inducingsecondary electrons which in turn generate a third and multiplegeneration electrons to the point where a sustainable plasma is created.This is dependent upon the total pressure of the system and thenecessary confinement of the plasma to prevent self-quenching. Withoutthese conditions it is unlikely that a plasma could be sustained or evenform at all. In laboratory practice, man-made plasma begins within nearideal vacuum conditions and is constrained by high energy magneticfields. In the industrial case, prolonged high energy input is requiredas in metal fabrication.

Superimposing the plasma paradigm in the surgical setting increases thealready manifold constraints governing creation of a plasma. Liquids asencountered in either endoscopic or in vivo conditions typical ofelectrosurgical applications are not the ideal medium for plasmaformation, as the energy needed to create an electron-ion pair ishigher, as energy first must be used to break molecular bonds. Intraditional plasmas, as mentioned above, a considerable amount of energyis needed to sustain a plasma for its intended purpose. In order tocreate and sustain a plasma condition in the body, itself constitutedlargely of water, it becomes evident that large amounts of energy wouldbe needed. It can be calculated that the energy needed to cause tissueablation, cutting, or coagulation, for example, via plasma would causeserious collateral harm to the patient. This circumstance provides asignificant problem for the plasma paradigm of electrosurgery.

The following calculations illustrate that a “plasma” does notcontribute significantly to the overall clinical effect ofelectrosurgery. The energy current needed to vaporize water and thensufficiently ionize the remaining molecules into a plasma is beyond theenergy input of the electrosurgical system. Further, the electrosurgicalsystem exhibits impedance rather than conductivity within the instrumenteffecter area.

The phenomenon of electrolysis and oxy-hydro combustion provides a moreaccurate alternative to the plasma paradigm. It is generally acceptedthat an electrosurgical probe system must create a “vapor pocket”immediately about the active electrode surface in order for anyplasma-like activity to become evident. As an example, this requires thecomplete vaporization of a 0.9% by weight solution of sodium-chloride indeionized water. Any such dilute solution will result in a boiling pointelevation and require additional energy input to reach the saturatedvapor state. The typical boiling point elevations for such solutionsrange from 1%-5% and can be considered negligible for the purposes ofthis exercise (i.e. a saline solution will not boil at exactly 100° C.,but rather on the order of 101° C. to 102° C. depending on the specificambient pressure conditions of the fluid field). If we assume that watermakes up the bulk of the components in question and look to thethermodynamic requirements to boil water on a per-pound-mass basis, itis known that:

$\begin{matrix}{{{m \cdot {Cp}_{H_{2}0} \cdot \Delta}\; T} = {1150.4\frac{BTU}{{Lb}_{m}}}} \\{= Q_{LHV}}\end{matrix}$

When converted to Watts on a per second basis:

$Q_{LHV} = {1213.7\frac{kW}{{Lb}_{m}}}$

If we consider that the amount of fluid immediately surrounding theelectrode tip is on the order of one-hundredth of a fluid ounce (0.01oz.), then the energy of vaporization converted to a per-second basisis:

$Q_{LHV} = {790\frac{W}{(0.01)\; {{Oz}.}}}$

From this simple thermodynamic analysis, it is evident that givengeneric electrosurgical console output on the order of 180-260 W/sec, alarge portion of the energy present is required to initiate vaporizationat standard temperature and pressure (STP) conditions. This approximates3 seconds of full power input to create an adequate vapor pocket for any“plasma” to begin forming. Furthermore, additional energy input beyondthe latent heat of vaporization (LHV) is required to perform additionalmolecular excitations that would result in the stripping of electronsfrom the constituent atoms within the gaseous solution. It appears thata disproportionate amount of energy would be required to maintain thebasic continual vaporization of water as it is continually refreshed inthe surgical environment, i.e. not in a fixed pressure vessel, let aloneperform higher energy dissociations of constituent sodium atoms.

In an alternative analysis, it is noted that plasma states of matter, ashighly ionized gas conditions, are known to be excellent electrical andthermal conductors due to the rapid Brownian motion of the constituentatomic particles and freely available electrons for conduction ofcurrent. This suggests some specific behavioral characteristics whichcan be illustrated simply.

Given that the ionization energies of typical atomic elements can beexpressed as:

X→X⁺ +e ⁻

and given that this value is known for sodium (D. W. Oxtoby, N. H.Nachtrieb. Principles of Modern Chemistry. Saunders College Publishing,N.Y., N.Y. 1986; pp. 438-439):

IE₁=496 kJ/mol; IE₂=4562 kJ/mol

and given that these values can be converted to Watts:

$495\text{,}720\frac{W \cdot {Sec}}{Mol}$

Then given a 0.01 oz. estimate of the total volume of the saline fluidimmediately surrounding the active electrode approximating the basicdensity of the fluid to be equivalent to that of water (a reasonableapproximation), the mass of fluid can be calculated:

${1.0443 \times 10^{- 5}{{ft}^{3} \cdot 62.4}\frac{{Lb}_{m}}{{ft}^{3}}} = {6.48 \times 10^{- 4}{Lb}_{m}}$

At the standard solution content of 0.9% by weight NaCI:

6.48×10⁻⁴ Lb _(m)×0.009=5.8×10⁻⁶ Lb _(m)(NaCl)

Converting value to grams yields:

2.6×10⁻³ gr(NaCl)

Given the Molecular Weight of NaCl, 58.44 gr/mol, it is clear that onlya fraction of a mole of the sodium chloride is present:

4.44×10⁻⁵ =Y _(fraction)

By corollary, a similar order of magnitude fraction exists for sodiumalone. Thus, it can be estimated that a 10⁻⁵ molar proportion of sodiumis present at the electrode tip and would require additional ionizationenergy IE₁ on a per-second basis as follows:

${496{\frac{kJ}{Mol} \cdot 1} \times 10^{- 5}{{Mol}({Na})}} = {4.95 \cdot {Watts}}$

This energy is in addition to that required to maintain continualvaporization of the saline fluid. Thus, the total minimum energyrequired to maintain any plasma-like activity immediately about theelectrode tip can be described as the sum of IE₁ and LHV.Mathematically, on a per-second 0.01 oz. basis:

IE ₁ +Q _(LHV)=4.95·W+790·W≈795·W

This result remains in discord with the fact that most commonelectrosurgical consoles are only capable of emitting 250 Watts ofelectrical energy. More than triple such energy is required to satisfythe thermodynamics of plasma creation.

The electrical conduction characteristics of all plasmas are fairly wellknown and are most plainly called conductors. Plasmas do not exhibithigh impedance characteristics that are common to simple gas volumes.Because they are highly ionized, there are sufficient free electrons toeasily conduct current and as such do not provide significant impedanceto current flow. A generic characteristic curve for a plasma's impedanceprofile once established is set forth in FIG. 13. The response curve ofa typical electrosurgical probe from a power versus impedance standpointis significantly different from typical plasma behavior. In the fluidstate prior to “vapor pocket” formation, electrical conduction dominatesthe mode of transmission and impedance slowly rises with the temperatureof the fluid. When vaporization results in nucleate boiling, theimpedance begins a sharp rise and immediately “spikes” when full filmboiling is initiated, i.e. the “vapor pocket.” The characteristic curvefor the impedance versus power of a typical immersed electrosurgicalprobe is as in FIG. 14.

It is evident that plasma would not behave electrically as doesoperation of an electrosurgical probe, because plasma would be an idealconductor and show net reduced impedance to current flow once plasma wasestablished. This is clearly not the case in the manifestation of atypical electrosurgical probe.

For the purposes of further analysis, the thermo-chemical approximationsof water rather than a 0.9% NaCl aqueous solution can be utilized, againunderestimating energy requirements, on the assumption that the initialstate of the water starts out at approximately 25° C. and must result infull film boiling, approximately 100° C., to sustain the “vapor pocket”required for a “plasma.”

If the volume of water that is to be affected equals 0.3 cm³, then toinitiate full film boiling:

$Q_{SV}:={{\frac{{Cp}_{H\; 2\; 0}}{{MW}_{H\; 2\; 0}} \cdot \left( {75\mspace{14mu} K} \right) \cdot 0.3}\mspace{14mu} g}$

Such that:

Q _(SV)=94.073J

This is the energy input required to achieve the saturated liquid state.Insufficient energy exists to fully vaporize water; for that anadditional energy input is required, the energy of vaporization or LHV.Therefore, further input of the following amount of energy is required(Lide D R, Ed. CRC Handbook of Chemistry and Physics. CRC Press, 83rdedition, 2002):

$Q_{LHV}:={1150.4{\frac{Btu}{lb} \cdot 1055.5}{\frac{J}{Btu} \cdot 1}{\frac{lb}{453.6\mspace{14mu} g} \cdot {MW}_{H\; 2\; 0}}}$

Such that:

$Q_{LHV} = {4.821 \times 10^{4}\frac{J}{mol}}$

Thus, the total energy required to maintain a saturated “vapor pocket”would require a total energy input of:

$Q_{input}:={Q_{SV} + {{Q_{LHV} \cdot 0.3}\frac{g}{{MW}_{H\; 20}}}}$

Such that:

Q _(input)=897.146J

If it is assumed that it is actually plasma that is the driving forcethat will generate the 897.14 J required to vaporize the water, it iseasy to evaluate the “plasma current” that is required to achieve thisprofile. The energy input would be required to produce EV particles inat least the quantity of the LHV and actually requires additional energybeyond this as the water is consuming it in a change of state process.Thus, using the LHV as a benchmark for the energy input, as it is theabsolute minimum requirement for a plasma, it then follows that theactual number of elementary charged particles required to vaporize the0.3 g sample of water is:

$\frac{Q_{input}}{eV} = {5.6 \times 10^{21}\; {particle}}$

using the average energy/particle=1 KeV, which is based upon the averageelectric field to which all the particles would be subject. This valueis equivalent to the field produced by a typical electrosurgicalgenerator at full power where Vpk-pk≈1 kV or 1 keV. To properly accountfor the aggregate charge of the particles, the total number of particlesis divided by 1,000, thus yielding:

$\frac{Q_{input}}{{eV} \cdot 1000} = {5.6 \times 10^{18}\; {particle}}$

1 keV particles at the ambient electric field strength produced by atypical electrosurgical generator, which is a fraction of a coulomb asfollows:

$\frac{Q_{input}}{{eV} \cdot 1000 \cdot {ParticlesperCoulomb}} = {0.897\mspace{14mu} C}$or:$\frac{Q_{input}}{{eV} \cdot 1000 \cdot {ParticlesperCoulomb}} = {0.897\mspace{14mu} s\mspace{20mu} A}$

This value can be classified on a per second basis as 0.9 Amp of“Arc-Current” (an extremely high current flow for an arc). It is clearthat with approximately 90% of a Coulomb of charged particles there isample availability for conducting electricity. In fact, at such a highconcentration of charged particles the net resistance of any such volumewould be extremely low. This finding conflicts with the behavior of thetypical electrosurgical probe which exhibits a “capacitor” like behaviorat the point of “plasma-like” transition. Such behavior should not bepresent with nearly a Coulomb of particles to conduct current. The netresistance of the system should drop at the point of plasma formation tonear zero.

With this background information at hand, a series of experiments wasconducted to further clarify the relevant parameters of electrosurgery,as disclosed in FIGS. 5A and 5B, which is centered on the electrolysisand oxy-hydro combustion physiochemical process in order to developmethods and devices for the detection and measurement of the relevantparameters of electrosurgery. Specifically, experiments were designedand performed to determine the existence and relative strengths of lowlevel ionizing radiation if any, present within the electrosurgicalprocess.

In one protocol, illustrated in FIG. 5A, the presence of ionizingradiation that might be produced in a saline solution (0.9% NaCl) with astandard electrosurgery tool was measured using radiation detector probe270 and particle detector measuring and display unit 300 to monitor thetreatment field for x-ray generation. Industrially acceptedelectrosurgical generator 310, set at a power setting of 900 Volts peakto peak at 460 kHz±1% and 245 Watts nominal maximum output power, wasutilized, representing a relatively high energy configuration typicallyutilized in an ablation mode of electrosurgical operation. This highenergy level was utilized to create the most advantageous situation forionizing radiation to form if possible. Bi-polar electrosurgical probe260 was activated, using radiofrequency electrosurgical generator 310 in0.9% by weight sodium chloride solution 290 in glass reservoir 280 untila yellow discharge optical emission was observed as described in Stalderet al. This color is more correctly described (as opposed to theconsideration of Stalder et al. discussed above) as the result ofelectron excitation, not to be confused with electron loss, and showsthe standard color associated with the 590 nm wavelength light asdepicted with optical emission instrumentation. Radiation detector 270,connected to particle detector measuring and display unit 300, sensitiveto 200 disintegrations per minute, was mounted on the beaker adjacent tothe probe 260 in solution 290. As discussed above, any plasma formation,even at a low scale, would result in free electron ion pairs and therelease of low energy x-rays, due to liquid/electron interfaceinteractions. Considering that the potential low energy x-rays thatmight be generated in the experimental apparatus would not havesignificant energy to penetrate glass electrolyte reservoir 280,radiation detector 270 was placed approximately 1 mm away from theair-water interface when probe 260 was activated. At this distance, 0.5keV x-rays would be transmitted. Should a plasma be formed byelectrosurgical probe 260 in any appreciable quantity above normalbackground radiation, the resultant ion-electron/solid interaction wouldresult in the generation of x-rays. X-rays can be generated when anelectron loses energy or when bound electrons in atomic shells areremoved by ionizing radiation. The removal of shell electrons emits acharacteristic x-ray with energies from a few keV to over 100 keV.Characteristic x-ray production for oxygen and sodium, for example, arebelow one keV. The slowing or break-off of the electrons results inwhite radiation or bremsstrahlung photons. These photons would have arange of energies on the same magnitude of the characteristic elementalx-rays. During light emission of the electrosurgical process, nodetectable x-rays were sensed by radiation detector 270. Radiationdetector 270, sensitive to 1 mrem/hour (200 disintegrations per minute),indicated no radiation above standard background radiation in which alltissue resides on earth. Since background radiation exposure averagesapproximately 2.5 milli-Sivert (0.01 SV=1 rem; 2.5×10⁻³ Sivert=2.5×10⁻⁵rem), 80% of which is natural radiation (half of which is due to radon)and 20% is man-made, ionizing radiation at those levels that mightdevelop during electrosurgical procedures is irrelevant to treatmentprotocols.

FIG. 5B illustrates an additional experiment that was performed usingunexposed x-ray film 330 in x-ray film case 320 to integrate a timeexposure function that radiation detector 270 might have been unable todetect. Again a power setting of 900 Volts peak to peak at 460 kHz±1%and 245 Watts nominal maximum output power was utilized fromelectrosurgical generator 310 to energize probe 260. Fluid reservoir 280was filled with 0.9% by weight NaCl solution 290 and probe 260 was fullyimmersed and placed within 1 mm of the glass wall of the reservoir.Probe 260 was then activated, and the normal yellow discharge becamevisible. Probe 260 was fired for 30 continuous minutes allowing any highenergy phenomenon, if present, to present itself by allowing any highenergy particles, x-rays, or free electrons escaping from the activeelectrode area to integrate over time and thus expose the film. Controlsource 265 of alpha (α) particles was adhesively affixed to x-ray filmcase 320 to demonstrate exposure to the film from high energy particlespenetrating the film case for an extended period of time. After 30minutes of exposure to both the firing probe and control α-particlesource 265 only the area exposed to a-particle source 265 was exposed.The film area immediately adjacent to the electrode remained unexposedand clear of any image.

These experimental results, based upon the premise that ionizingradiation will produce detectable x-rays exceeding background levels,invalidate plasma formation as a means to achieve the effects of theelectrosurgical process. Single ionizing events may occur on atheoretical basis, but would do so at a limit well below detection, andcertainly would not be sufficient for any tissue treatment protocol. Asan example, a theoretical mathematical exercise was conducted in whichthe assumption was made that plasma actually does form at a maximumenergy level equal to background levels of 200 dpm(disintegrations/minute) or 3 dps (disintegrations/second). In theexperimental set-up, it was estimated that the air-water interfacereduced the total transmittance by a factor of 100 and the solid angleeffect of the detector accounted for another factor of 1000 reduction.Using the transmittance reducing elements to estimate thedisintegrations per minute of the plasma at its core, then we have(10²×10³×10¹×60 dps/dpm) or [air/water interface reduction]×[solid angledetector effect]×[nominal background level order of magnitude]×[min tosec. Conversion of 10], or a value of 10⁷ dps, which is approximated asan x-ray yield from the electrosurgical tool during discharge. If eachx-ray is the result of a single charged particle or free electron/solidinteraction, which is a gross idealization erring on the side of highercharged particle/x-ray ratio, a maximum amount of ionized particles of10⁷ is possible. We know the energy of the charged particle is on theorder of 1 keV, or approximately 10⁻¹⁶ Joules per particle. Multiplyingthe total ideal theoretically available particles by the maximum energyper particle (10⁷×10⁻¹⁶) yields a total energy per second capacity onthe order of 10⁻⁹ J, or a nano-Watt for the ion component. Since chargedparticles at 1 keV would travel no more than 100 Å, the total effectedvolume would be extremely and impracticably small. Since grossobservation of the electrosurgical process and its function clearlydemonstrate effects of the probe at ranges past a centimeter, theeffects of an electrosurgical apparatus typically utilized for medicaltreatments cannot be due to such low level ionizing radiation, if itexists at all, as demonstrated by distances employed in practice.Theoretical single or small scale random and uncontrollable ionizationevents would be more reasonable terminology to describe any suchcreation of ions and electrons in the solution relative to treatmentgoals rather than plasma formation for those so inclined. Since thecreation of ionizing radiation is not detectable above backgroundradiation noise in which all tissue resides here on earth, the mechanismfor electrosurgical procedures and the corresponding tissues effects areunrelated to these hypothetically proposed low level ionizing radiationoccurrences.

Further, evaluation of the well known interaction of ionizing radiationwith cells adds more evidence that ionizing radiation does not play arole in the electrosurgical treatment process. Ionizing radiation whenapplied to cells or tissue leads to molecular changes and to theformation of chemical species that are damaging to cellularconstituents, such as chromosomal material. Such damage leads toirreversible alterations in the function and construction of the cellitself, damage that is readily observed histologically. The process thatoccurs when ionizing radiation is applied to the cell begins withconversion of water after ˜10⁻¹⁶ seconds. This is depicted asH₂O→H₂O⁺+e⁻ with the application of ionizing radiation. The nextoccurrences are as follows over the next ˜10⁻⁶ seconds: H₂O⁺→H⁺+OH;H₂O+e⁻→H₂O⁻; H₂O⁻→H+OH⁻. H and OH are considered free radicals andparticipate in further reactions. The most prominent is the formation ofhydrogen peroxide as follows: OH+OH→H₂O₂. These products react with theorganic constituents of the cell and tissue, such as nucleic acids andhydrogen extraction from pentose, to release organic free radicalsinduced by radiation damage. Histological evidence of theelectrosurgical process as disclosed in U.S. patent application Ser. No.10/119,671 clearly does not provide evidence of radiation induced tissuedamage at any level of linear energy transfer. Histological evidencedemonstrates levels of necrosis, such as karyorrhexis and nuclearpicnosis at one end of the spectrum to frank necrosis or vaporization atthe other end of the spectrum, as would be expected from electrolysisand oxy-hydro combustion. It would be expected that any ionizingradiation effects, should they occur in electrosurgery, would havemanifested themselves long term as local radiation injury, given thatelectrosurgical methods and devices have been in wide spread use forover 50 years. The disparity between the description of electrosurgeryin the prior art as governed by plasma formation and/or ionizingradiation and concerns for the induction of ionizing radiation-relateddisease is readily apparent in prior art and the medical literature.This evaluation of radiation induced cellular and tissue changes addsadditional evidence that sensing and measuring devices developed for therelevant parameters of electrosurgery would not include those that maydetect hypothetical and necessarily irrelevant low level ionizingradiation.

The foregoing disclosure helps to define the relevant parameters ofelectrosurgery as related to electrolysis and oxy-hydro combustion asdisclosed hereafter.

The equations of FIG. 1A illustrate the chemical equations that describethe overall oxy-hydro reaction, with associated acid-base shifts,resulting from electrolysis of water and subsequent ignition of theresulting oxygen and hydrogen. The physiochemistry of theelectrosurgical process consists of an acid-base shift that governs therelative availability of the amount of water that can be consumed aspart of an electrolysis chemical reaction. The electrolysis reaction isdriven by the high frequency current flowing between active and returnelectrodes in both the bi-polar and mono-polar modes of operation ofelectrosurgical probes. This oxy-hydro combustion theory accounts forall necessary chemical and energy constituents that are present as wellas the physical observations of light emission and heat generationduring the use of such devices. This description reconciles thephysiochemical occurrences of electrosurgery into a single accurate andcohesive theory.

Chemical equations 10 generally govern the process, whereby the initialliberation of elemental oxygen and hydrogen gases 30 occurs by means ofelectrolysis. Given that the underwater electrosurgical process occursin a salt solution, either that applied as an irrigant or that of thetissue or cell itself, such as a 0.9% by weight saline solution, thetrue role of these elements has been reconciled. The presence and trueaction of the salt, such as sodium chloride (NaCl), can be accounted forby means of equations 10. The normal stoichiometry of the electrolysisreaction dictates that if elemental gas separation is occurring, thenthe solute participants must join with the remaining solution componentsof water to form a complementary acid-base pair. This pair is shown onthe right-hand side of the upper half of equations 10 as hydrochloricacid 15 and sodium hydroxide 20 base pair. As is well known, hydrogenand oxygen gases 30 can be co-mingled without spontaneous exothermicreaction. A small amount of energy, such as RF energy 40, is required toinitiate the nominally endothermic reaction and ignite the oxy-hydrocombustion. Once ignited, the reaction will continue until all thereactants are consumed and reduced to the products shown on theright-hand side of the lower half of equations 10.

The equations of FIG. 1B illustrate the effect of the acid-basethrottling reaction. The oxy-hydro combustion process depicted isdynamic and occurs in a fixed fluid reservoir, which necessarily resultsin dynamically changing concentrations of salt ions as a function ofelectrolytic conversion of water to elemental gas. This equationnecessarily suggests that as the acid-base shift occurs in thereservoir, less and less water is available for electrolysis. Thisphenomenon is seen in FIG. 1B where acid-base pair 15 and 20 is shown inincreased molar proportion to the normal stoichiometric quantity of basereactions 10. The reduction of available water for electrolysis isevident in relationship 50 of oxygen and hydrogen gas to the acid-basepair. The finding is necessarily evident from the stoichiometry, namelythat insufficient water is available given a fixed initial eight (8)moles of water, based on the finite reservoir of water, with increasingresulting molar concentrations of acid and base as oxygen and hydrogenare liberated from the solution in a gaseous state, such as by bubblingout of solution. As fewer moles of oxygen and hydrogen gas are presentafter electrolysis as in FIG. 1B, the balancing portion of atoms accountfor the dynamic increase acid-base concentration.

The equations of FIG. 1C demonstrate a more general case of theelectrolysis and oxy-hydro combustion reaction process in which theionic salt is represented by variable 60, where X is any appropriategroup I, period 1-7 element of the periodic table. This generalizedreaction illustrates how hydronium and hydroxide ions can contribute tothe same overall chemical reaction known as electrolysis and oxy-hydrocombustion.

The equations of FIG. 1D demonstrate the more general case of theelectrolysis and oxy-hydro combustion reaction process in which theionic salt is represented by variables 61, consisting of α, β, γ, and δ;wherein, the molar quantities required for stoichiometric combustion areany value that appropriately satisfies the oxidation reduction valencerequirements for the overall reaction. This generalized reaction caseshows how oxygen and hydrogen requirements can vary and still result inthe same overall chemical reaction known as electrolysis and oxy-hydrocombustion.

The modes of electrolysis and oxy-hydro combustion operation describedin FIG. 1A, FIG. 1B and FIG. 1C depict theoretical stoichiometricreaction processes induced by application of high frequencyelectromagnetic energy to a salt ion solution, including salt ionsolutions typically found within biologic tissues themselves. Thefundamental process is governed by the rate of electrolysis in theinitial dissociation of water into oxygen and hydrogen gas, as shown inequations 10.

A preferred embodiment of the present invention disclosed herein is useof thermo-luminescent crystals 160 as depicted in FIG. 3. An example ofcrystals that demonstrate linear temperature to luminescent profiles aredescribed in Buenfil AE et al. Dosimetric Properties of europium-dopedpotassium bromide thermoluminescent crystals. Health Physics, Vol.62(4):341-343, 1992. Crystal 160 is an encapsulated thermo-luminescentcrystal in thin-walled zirconia shell 155, with a nominal thickness of0.0001-0.002″, providing shielding against thermo-chemical degradationof the potassium bromide crystal in harsh immersion environments, asshown in FIG. 3. FIG. 3 thus depicts an electrosurgical probe immersedin electrolyzable aqueous media 166. In the probe, active electrode 150is connected to active conductor wire 200, which in turn is connected toa power supply. The power supply, for this and all other embodimentspresented herein, can provide radiofrequency energy at any frequency,and can alternatively supply direct current energy, pulsed directcurrent energy, or the like. The probe is partially encased withininsulating sheath 210, with exterior return electrode 170. In operation,light 165 is emitted from thermo-luminescent crystal 160 in response togenerated heat. The detector system can further include fiber opticelement ball ended lens 180 connected to light sensing optical fiber190, located such that only light generated by crystal 160 isaccumulated by lens 180. The creation of such a device is possiblethrough one of several means by which zirconia is deposited on thesurface of the thermo-luminescent crystal and subsequently hardened, oralternatively by a simple double barrel pulse injection moldingprocedure familiar to those skilled in that art. Use of super-plasticzirconia ceramic alloys is beneficial to avoid green-to-cured statecontraction in molecular spacing as theoretical density limits areachieved through the kilning process used to cure the ceramic. Asgeometric reductions of 20-30% are normal for ordinary zirconium alloys,this can be easily offset by the 100-150% elongation capabilities of asuper-plastic alloy of zirconium. Kim B N et al. A High Strain-RateSuperplastic Ceramic. Nature, Vol. 413, 20^(th) September, 2001, pp.288. As the thin-walled protective shield of zirconia is thin enough tobe semi-transparent at such cross-sectional area, the color-shift of theglow-curve of the thermo-luminescent crystal is easily visible throughthe zirconia and can be visibly detected by the human eye under ordinarylighting conditions. Console control algorithms 120 and 130, FIG. 2A andFIG. 2B, are fed an input signal from ball lens fiber optic element 180in FIG. 3, which is used to transmit the luminescence from thetemperature sensitive crystal to a photo-detector or colorimeter. Thephoto-luminescence is transformed via analog to digital flip-flopcircuitry into a digital signal of streaming data and recorded in timeintegration sampling circuitry, well known to those skilled in the artof real-time data sampling. The data stream is modified by numericalsoftware algorithms 70 to provide a stable control variable. The stablecontrol variable is used in traditional data comparison algorithms 80 toperform electrosurgical console radiofrequency power output “throttling”via inverse proportionality control circuitry 90, well known to thoseskilled in the art of power output control systems. The circuitryperforms real-time correlation of sensed color shifts by thethermo-luminescent crystal in response to temperature changes on thesurface of the probe tip. The optical fiber is placed immediatelysub-surficial to the exterior of the electrode-insulating member suchthat a focusing “lens-effect” is utilized to transmit thethermo-luminescent crystal color to the control circuitry.

Yet another embodiment is the use of thermo-luminescent crystalmaterial, such as those described above, as depicted in FIG. 10 wherethe thermo-luminescent crystal material is used as an insert forthermo-luminescent crystal “beacon” 440 within the insulator in a boreat the extreme distal end of the insulator where the active site of theelectrosurgical device exists. When the thermo-luminescent crystal isformulated in a manner such that the chemical structure of the crystalis hydrophobic (by way of example an optically clear silica glassdeposition coating may be applied to the crystal which does not dissolvein aqueous environments), the crystal can actually become external tothe insulator and provide combined feedback of device and treatment sitetemperatures. In one alteration of the chemistry, europium doping ofzirconia-yttrium ceramic can be employed such that thethermo-luminescent function becomes that of ceramic insulator 450itself.

Yet another embodiment is shown in FIG. 4 wherein use of an instrumentintegrated pH monitoring system comprising a reference potential and useof glass bulb capacitive pH detector 240 is described. The micro glassbulb detector 240 is connected to pH potential conductor wire 250. Inthe embodiment depicted in FIG. 4, the probe further compriseseuropium-doped thermoluminescent yttria-stabilized-zirconia insulatingmember 230 for temperature detection, and acid/base shift fluid outflowportal 220, it being understood that these elements representalternative embodiments. The pH monitoring system is coupled viaelectrical connection 250 to control circuitry for governing multipleparameters of the electrosurgical environment. FIG. 2B depicts suchcircuitry providing both differential feedback for electrosurgicalconsole output parameters 140 and integral feed-forward control 145 ofadjunct devices that can provide additional inputs to the surgicalfield, such as surgical irrigation systems and pumps for irrigationsystems, as disclosed in U.S. patent application Ser. No. 10/157,651,entitled Biologically Enhanced Irrigants, filed May 28, 2002. Forexample, measurement of pH has been determined to be an effective methodto monitor the electrolysis that occurs in tissue. Guy Finch J et al.Liver electrolysis: pH can reliably monitor the extent of hepaticablation in pigs. Clin Sci (Loud) 2000; 102(4):389-395.

FIG. 6 illustrates yet another embodiment of the configuration of anelectrosurgical probe wherein the distal tip insulator includes athermo-luminescent crystal 230 and contains an array of multipleindependent optical fibers 190 and 195 configured to provide adistributed profile of surgical site field conditions. Each independentoptical fiber is a single or multi-mode fiber utilizing “ball-end”focusing lens 340 and 345 to provide means for viewing and determining“free-field” bulk property conditions at a predetermined focal lengthexternal to the probe, thermo-luminescence colorimetry/thermometry atthe surface of the probe, and oxygen and hydrogen gas production usinggas filter correlation radiometry or Fourier infra-red spectroscopythrough optical switching performed within the control unit. In oneembodiment, the methods disclosed in U.S. Pat. No. 5,128,797 can beemployed.

FIG. 7A and FIG. 7B depict yet another embodiment of an electrosurgicalprobe comprising a distal active electrode 150 and a proximal returnelectrode 170 separated by an insulator wherein is disposed conductivitymeter pair electrodes 350 and 360 for sensing acid-base shifts due tothe byproducts of electrolysis induced by electrosurgery. Cylindricalconductivity electrode 350 is electrically connected to conductivitysensing voltage conductor wire 380, and electrode 360 is similarlyconnected to wire 370, it being understood that either electrode 350 orelectrode 360 can serve as a reference electrode. In FIGS. 7 and 7A,insulating member 230 is provided, which may optionally be aneuropium-doped thermoluminescent yttria-stabilized-zirconia insulatingmember. The conductivity meter is electrically coupled toproportionality circuitry 140 for providing both differential feedbackfor electrosurgical console output parameters and integral feed-forwardcontrol 145 of adjunct devices that can provide additional inputs to thesurgical field, such as surgical irrigation systems and pumps similar tothose disclosed in U.S. patent application Ser. No. 10/157,651.

FIG. 8 depicts yet another embodiment of an electrosurgical probeincluding a distal active electrode and a proximal return electrodeseparated by an insulator wherein is disposed piezo-acoustic sensor 390positioned on the surface of the insulator and connected by means ofconductor wire 400. Piezo-acoustic sensor 390 may, in one embodiment, bea piezo-acoustic drum vibration transducer. Oxy-hydro combustionpressure waves created at the active electrode during electrosurgery aredetected and transformed into electrical signal outputs. Theseelectrical signals can be comparatively analyzed against numericallyregressed curves of oxy-hydro combustion signature acoustic intensity incontrol algorithms 130, as depicted in FIG. 2B. The acoustic sensor iselectrically coupled to proportionality circuitry for providing bothdifferential feedback 140 for electrosurgical console output parametersand integral feed-forward control 145 of adjunct devices that canprovide additional inputs to the surgical field, such as irrigationsystems and pumps similar to those disclosed in U.S. patent applicationSer. No. 10/157,651. Additionally, piezo-acoustic sensor 390 can be usedto detect Doppler sound shifts using time integration circuitry 120, asdepicted in FIG. 2B, with information about known irrigation fluiddensity correlated from impedance control circuitry to perform basicdensitometry, thereby detecting acid-base shifts due to the by-productsof electrolysis induced by electrosurgical procedures. Thedensitometry/acoustic sensor is electrically coupled to proportionalitycircuitry 140 for providing both differential feedback forelectrosurgical console output parameters and integral feed-forwardcontrol 145 of adjunct devices that can provide additional inputs to thesurgical field, such as irrigation systems and pumps similar to thosedisclosed in U.S. patent application Ser. No. 10/157,651.

FIG. 9 depicts yet another embodiment of an electrosurgical probeincluding a distal active electrode 159 and a proximal return electrode170 separated by an insulator 230 wherein is disposed a pH-metercomprising a single wire ion meter 420 comprised of Mg—Ni or similarmaterial connected to pH potential conductor wire 250 to detectacid-base shifts due to the byproducts of electrolysis induced byelectrosurgical procedures. The pH sensor is optionally electricallycoupled to proportionality circuitry 140 for providing both differentialfeedback for electrosurgical console output parameters and integralfeed-forward 145 controls of adjunct devices that can provide additionalinputs to the treatment field, such as irrigation systems and pumpssimilar to those disclosed in U.S. patent application Ser. No.10/157,651.

FIG. 10 depicts yet another embodiment of an electrosurgical probeincluding an active electrode 150 and return electrode 170 separated byan insulating member 450 wherein is disposed at the distal tip athermoluminescent crystal member 440 embedded in primary insulatingmember 450. The thermoluminescent crystal member acts as a “beacon” oflocalized temperature at the surgical site, providing means forvisualization of real-time temperatures at the treatment site,additionally providing means to sense and display visual cues oftemperature that are immune to interferences from propagatingelectromagnetic waves. The crystal element includes Europium-dopedmagnesium bromide crystalline structures. The crystalline structure isstabilized for the electrosurgical environment by means of an opticallyclear coating, such as a quartz silica glass or polymethylmethacrylatepolymer. The thermo-luminescent crystal is disposed on the distalportion of the insulating member in proximity to active electrode 150.The energy flux between the active and return electrodes is the sourceof energy that drives electrolysis equations 10 and in so doinggenerates heat within the fluid surrounding the active electrode. Theheat generated is both convectively and conductively transferred throughthe irrigant media and or tissue, depending upon treatment methods, andconvectively and conductively heats insulating member 450 withthermo-luminescent element 440 disposed at the distal tip of the probe.As thermo-luminescent element 440 is heated, molecular excitations causeelectron orbital fluctuations and the release of photons of knownwavelength. As the light and color shift of the crystal are correlatedto its ambient temperature a direct visual aid is created that directlydemonstrates the temperature of the energized probe. The clinician canthen respond immediately to luminescence shifts in thermo-luminescentelement 440 to appropriately meter probe activation and tissue treatmentas well as power set points on the electrosurgical controller.

FIG. 11 depicts yet another embodiment of an electrosurgical probewherein the sensor is pyrometric sensor 460 constructed of a thin-filmthermal-electric compound, such as bismuth-telluride (available from theHi-Z Corporation of San Diego, Calif.) connected to transducer conductorwire 400. This thermo-electric sensor is optionally electrically coupledto proportionality circuitry 140 for providing both differentialfeedback for electrosurgical console output parameters and integralfeed-forward 145 controls of adjunct devices that can provide additionalinputs to the treatment field, such as irrigation systems and pumpssimilar to those disclosed in U.S. patent application Ser. No.10/157,651.

FIG. 15 depicts an embodiment of an electrosurgical probe which providesa means for maintaining the optimal spacing of active electrode 150,disposed distal from the primary lumen 141 which also acts as a returnelectrode. Actuating arm 531, which in turn is driven by electricpositioning motor 530, actuates translatable sheath 181. Translatablesheath 181 thus can extend the insulating properties of insulator 151beyond the end profile or position of active electrode 150, providingmeans to create a variable volume localized chamber when thetranslatable sheath 80 is extended. In an alternative embodiment,translatable sheath 181 can be mechanically actuated, including by meansof a thumb control, which may incorporate gears or other means oftransferring energy, utilized by the operator. Thus translatable sheath181 may, in one embodiment, simply be frictionally engage with a thumbcontrol or other means of movement, may be mechanically actuated, or maybe electro-mechanically actuated, as in FIG. 15. In one embodiment,sensor 391 provides primary control variable feedback to differentialcontroller 501, optionally as an analog input. If the input is analog,it may be output via flip-flop A/D conversion to a digital controlsignal for use by application-specific integrated circuitry logiccontroller 511, such as an FPGA, MOSFET, or similar intermediate digitallogic gate controlling array. Flash RAM, and additional high levelinput/output governance, is controlled by CPU 521, utilizing softwaregoverned database lookup techniques, such as those commonly known in C+or C++ programming code, to provide dual proportional output via PrimaryRF Output Controller/Generator 522; and further and optionally also toElectronic Positioning Controller 523 for simultaneous balancedpositioning of translatable sheath 80 coupled to matched power settingthrough controller 522, providing the primary controlling input to matchuser set-points according to primary control variable knowncharacteristics correlation to a desired set point. Electrical power maybe provided by wires connected to a suitable source of power, which maybe one or more sources of power, such as a high voltage source foroperation of the active electrode and a lower voltage source foroperation of the circuits provided. In the embodiment of FIG. 15, thedetector or sensor employed may be any detector or sensor describedherein.

It is further to be appreciated that a fixed cavity probe may beemployed, such that one or more active electrodes are disposed within acavity, the distal end of the probe ending beyond the end of the one ormore active electrodes. Return electrodes may be provided, which returnelectrodes can be within the cavity or without the cavity, and in oneembodiment are located on the exterior or interior surface of the probeon the portion of the probe forming a cavity. In this embodiment, one ormore detectors or sensors may be provided, preferably located within thecavity. However, detectors or sensors may also be integrated into theprobe body, such as by forming a part of the cavity wall, or may belocated on the exterior of the probe.

Other detectors or sensors may be employed to determine parametersrelevant to either electrolysis or to oxy-hydro combustion, or to both.In one embodiment, the detector detects local pressure changes, andincludes a pressure sensor. Such pressure sensor may be employed todetermine the position of a probe with respect to tissues, such aswhether the probe touches a tissue, or may alternatively be employed todetect local pressure changes relating to either electrolysis oroxy-hydro combustion. In another embodiment, the detector detectsconsumption of interfacing media, particularly oxygen or hydrogen, suchconsumption including consumption by oxy-hydro combustion.

It is to be appreciated that the same sensor or detector may detect aparameter relating to electrolysis and also a parameter relating tooxy-hydro combustion, and may further detect parameters relating to thetransition to oxy-hydro combustion. Thus electrolysis and oxy-hydrocombustion may occur successively or simultaneously, and therelationship thereof can be monitored and determined by means of datacollected by the sensor or detector.

It is also to be appreciated that any of the probes or devices disclosedherein may have two or more active electrodes, and may also have two ormore return electrodes. In some embodiments, the return electrode mayform a part of the body of the probe. Similarly, two or more differentdetectors or sensors may be provided, determining two or more differentparameters. Alternative, two or more detectors or sensors may beprovided, but at different locations on the probe, providing relevantinformation about either electrolysis or oxy-hydro combustion. Forexample, one temperature probe may be located at the distal end of theprobe, to measure temperature at the site closest to tissue beingtreated, while a second temperature probe may be removed some distance,such as by locating on an insulated exterior surface of the probe, todetermine the area of temperature change. Other such combinations andpermutations are both possible and contemplated.

FIG. 1A illustrates a preferred embodiment of the physiochemistry of theelectrolysis and oxy-hydro combustion reaction. The physiochemistry ofthe electrosurgical process consists of an acid-base shift that governsthe relative availability amount of water that can be consumed as partof an electrolysis chemical reaction. The electrolysis reaction isdriven by the high energy density/flux modes of operation ofelectrosurgical probes. FIG. 1A illustrates the chemical equation thatdescribes the overall electrolysis and wry-hydro reaction as it pertainsto electrosurgery in the underwater, cellular, and biologic environment.From this reaction it is noted that all the necessary chemicalparticipants are accounted for and that the physical observations oflight emission and heat generation are also accounted for. The series ofchemical equations 10 that govern the process first provide anelectrolysis function thereby liberating elemental oxygen and hydrogengas 30. Given that the entire electrosurgical process is typicallyobserved to occur fully immersed in a saline solution (0.9% by weight)the presence of sodium chloride (NaCl) must also be accounted for. Thenormal stoichiometry of the electrolysis reaction dictates that whenelemental gas separation is occurring, then the solute participants mustjoin with the remaining solution components of water to form acomplementary acid-base pair. This pair is clearly shown on theright-hand side of the upper half of equations 10 as a hydrochloric acid15 and sodium hydroxide 20 base pair. The hydrogen and oxygen gases 30can be co-mingled without immediate spontaneous exothermic reaction. Asmall amount of energy, such as the radio frequency energy 40 indicatedin the lower of equations 10, needs to be added to overcome thenominally endothermic reaction and ignite the oxy-hydro combustion. Onceignited, the reaction will cascade, or self-perpetuate, until all thereactants are consumed and reduced to the products shown on theright-hand side of the lower equations 10.

FIG. 1B illustrates a variation of the acid-base throttling reaction ofthe preferred embodiment. It is worthy of note that the entireelectrolysis and oxy-hydro combustion process is a dynamic process,occurring in a fixed reservoir of fluid, which necessarily impliesdynamically changing concentrations of salt ions, based on water volumeconverted to elemental gas. This suggests that as the acid-base shiftoccurs in the reservoir less and less water is available forelectrolysis. This reaction is clearly seen in FIG. 1B where theacid-base pair 15 and 20 is shown in increased molar proportion to thenormal stoichiometric quantity of the base reactions 10. The reductionof available water for electrolysis is evident in relationship 50 ofoxygen and hydrogen gas to acid-base pair. The explanation for this isevident from the stoichiometry-insufficient water is available, giventhe fixed eight (8) moles of water to start with a finite reservoir ofwater, and the increasing molar concentration of acid and base as theoxygen and hydrogen are liberated away from the solution in the gasstate, such as by bubbling out of solution. It is illustrated as fewermoles of the oxy-hydrogen gas present after electrolysis in FIG. 1B,wherein the balancing portion of the atoms account for the dynamicincrease acid-base concentration.

FIG. 1C illustrates the more general case of the electrolysis andoxy-hydro combustion reaction process wherein the ionic salt isrepresented by variable 60, X which could be any of the appropriategroup I, period 1-7 elements of the periodic table. This generalizedreaction case shows how the hydronium and hydroxide ions can contributeto the same overall chemical reaction known as electrolysis andoxy-hydro combustion.

FIG. 1D illustrates the more general case of the electrolysis andoxy-hydro combustion reaction process wherein the ionic salt isrepresented by variables 61, α,β,γ,δ, the molar quantities required forstoichiometric combustion could be any value that appropriatelysatisfies the oxidation reduction valence requirements for the overallreaction. This generalized reaction case shows how the oxygen andhydrogen requirements can vary and still result in the same overallchemical reaction known as electrolysis and oxy-hydro combustion.

Understanding of the foregoing reaction conditions makes clear theutility of sensors or detectors proximal to the active electrode forlocal measurement of relevant parameters, such as temperature, pH,conductivity, impedance, ion concentrations, gas production—particularlyhydrogen or oxygen production, and sound. Determination of relevantparameters allows adjustment in operation of the electrolysis probe,such as adjusting power, radiofrequency, electrolytic media flow orcomposition, and the like.

FIG. 2A and FIG. 2B illustrate both general and specific cases ofcontrol mechanisms by which relevant parameters of electrosurgicalprocess can be accurately governed. Ordinary signal transduction fromthe instrumentation corporeal contact part to the electrosurgicalcontroller is required to provide means for input signal recording usingtime integration circuitry 110 and performing subsequent mathematicaloperations 120 to condition the input signal so as to use it effectivelyas a stable control variable. For example, analog detector signalsacquired from any of the probes of FIG. 3, 4, 6, 7A, 7B, 8, 9, 10 or 11can be converted by analog-to-digital converter 100. After recordingusing time integration circuit 110 mathematical operations 120, such asmicroprocessor driven software algorithms, may be employed, optimallyusing software algorithms 130 for comparison of time-averaged datapoints against a determined data standard. Such mathematical algorithmscan include averaging, integration, differential rate of changecalculations, and the like. In a specific case, a simple time averagingalgorithm 70 of specified periodicity can be applied to the data streamto “smooth” the feedback signal and provide general control based onreal-time trend information of selected parameters. Such control outputcan be performed in the manner of ratio controlling 90 and 140 to“throttle” equipment output functions based on sensed/detectedparameters at the surgical site. Standard communications links 145 canbe used to interconnect adjunct equipment to the electrosurgicalcontroller or other ratio-controller that works in tandem with theelectrosurgical controller.

FIG. 3 illustrates use of encapsulated thermo-luminescent crystal 160 toperform real-time visual feedback to the practitioner of temperatureshifts at the treatment site. When active electrode 150 is energized andconducts high frequency electrical current to return electrode 170 thenormal process of electrolysis of aqueous media 166 immediately begins.The endothermic reaction requires the input of energy that subsequentlyheats the aqueous media, convectively and conductively heatingthermo-luminescent crystal 160. As the thermo-luminescent crystalemissions rise proportionally with temperature rise the luminance iscaptured by optical fiber ball end lens 180 and transmitted down opticalfiber 190 to an opto-electrical coupling within an electrosurgicalcontroller unit. The opto-electrically transformed signal thus providesmeans for input signal recording using time integration circuitry 110and performing subsequent mathematical operations 120 to condition theinput signal so as to use it effectively as a stable control variable.The mathematical algorithms can include averaging, integration,differential rate of change calculations, and the like. In this specificcase, a colorimetric averaging algorithm 120 can be employed from knowncolor correlating data to crystal dynamics to “quantize” the feedbacksignal and provide general control based on real-time trend informationof selected parameters. Such control output can be performed in themanner of ratio controlling 140 to “throttle” equipment output functionsbased on sensed/detected parameters at the treatment site. Standardcommunications links 145 can be used to interconnect adjunct equipmentto the electrosurgical controller or other ratio-controller that worksin tandem with the electrosurgical controller.

FIG. 4 illustrates use of pH sensing within the electrode-insulatorcombination to provide a stable control variable for governingelectrosurgical process. In this embodiment, miniature glass bulb pHsensor 240 is disposed within a semi-enclosed cavity of the electrodeinsulator combination 230 and 150. Acid-base shifted water canaccumulate within the cavity and flow out of acid-water outflow portal220. As the rate of electrolysis and oxy-hydro combustion increases ordecreases production of acid-base pairs also increases or decreases, andthus there are changes in pH of the immediate space surrounding activeelectrode 150. The pH signal is transduced along conductor wire 250,optionally to an analog to digital flip-flop circuit where the signal istransformed for use in software algorithms as a stable control variable.Such mathematical algorithms can include averaging, integration,differential rate of change calculations, and the like. In this specificcase, a logarithmic averaging algorithm 120 from acid-base shift ratesof change data correlated to electrolysis and oxy-hydro combustion ratesis employed to “quantize” the feedback signal and provide generalcontrol based on real-time trend information of selected parameters.Such control output can be performed in the manner of ratio controlling140 to “throttle” equipment output functions based on sensed/detectedparameters at the treatment site. Standard communications links 145 canbe used to interconnect adjunct equipment to the electrosurgicalcontroller or other ratio-controller that works in tandem with theelectrosurgical controller.

FIG. 6 depicts use of optical fiber sensing at and within the distal tipof a probe as part of an array of independently connected optical fibersproviding means to sense both internal and external to the distal tip ofthe electrosurgical probe. Internal optical fiber 195 uses ball endedlens 340 to collect light emitted from within the insulating member,such as a thermo-luminescent crystal or europium dopedyttria-stabilized-zirconia crystal 230. External optical fiber 190 usesa ball ended lens 345 to collect infrared light emitted from thesurgical site, with ball ended lens 345 being comprised of a sphericallens with a ground-in focal point of approximately 3-5 mm. The opticalfiber is optionally made of a single-mode silica glass optimized for thetransmission of infrared light, well known to those skilled in the artof optical fiber production. In an additional control algorithm,alternative ball end lens 345 can be optically switched at thecontroller unit to an alternative detector designed to measure gasproduction using gas filter correlation radiometry or Fourier infra-redspectroscopy. In this specific case, spectral averaging algorithm 120from electrolysis and oxy-hydrogen gas production rate data iscorrelated to thermal rise created by nominal electrolysis and oxy-hydrocombustion heat of reaction to “quantize” the feedback signal andprovide general control based on real-time trend information of selectedparameters. Such control output can be performed in the manner of ratiocontrolling 140 to “throttle” equipment output functions based onsensed/detected parameters at the treatment site. Standardcommunications links 145 can be used to interconnect adjunct equipmentto the electrosurgical controller or other ratio-controller that worksin tandem with the electrosurgical controller.

FIG. 7A and FIG. 7B depict use of conductivity electrode pair 350 and360 separated by insulating member 230 to sense the changes inconductivity that electrolysis induces through the creation of acid-basepairs. Electrolysis occurs when active electrode 150 is electricallyenergized and conducts current to return electrode 170, formingacid-base pairs which alter the natural conductivity of traditionallyutilized electrosurgical irrigants. As the resulting hydronium ionconcentrations are raised and lowered the conductivity of thesurrounding fluid is also raised and lowered. The generally acceptedmethodology for detecting conductivity is the application of a known DCvoltage across electrode pairs 350 and 360 while measuring the currentflow through the conductive media. Electrical conductors 370 and 380carry the current through a detection loop circuit within theelectrosurgical controller. In one instance, time averaging algorithm 70from acid-base pair conductivity shift data is correlated to pH changewhich in turn can be correlated to treatment response catalog data to“quantize” the feedback signal and provide general control based onreal-time trend information of selected parameters. Controllingacid-base pair production along treatment response constraints allowsfor improved overall treatment response and reduced collateral damage.Such control output can be performed in the manner of ratio controlling140 to “throttle” equipment output functions based on sensed/detectedparameters at the treatment site. Standard communications links 145 canbe used to interconnect adjunct equipment to the electrosurgicalcontroller or other ratio-controller that works in tandem with theelectrosurgical controller.

FIG. 8 depicts use of a piezo-electric acoustic sensor to transmit soundwaves generated by oxy-hydro combustion from the electrode-insulatorinterface to the electrosurgical controller. Piezo-acoustic sensor 390is tuned to operate in the 10 kHz to 600 kHz range of sound output. Fromthe probe specific response data, characteristic sound thresholds areestablished that allow the conducted analog acoustic signal carried intransducer conductor wire 400 to be converted via A/D flip-flop for usein software comparative algorithms 140. Each quantized acousticincrement can be accurately correlated to oxy-hydro combustion rates. Asactive electrode 150 is energized and completes the circuit with returnelectrode 170 the normal electrolysis phenomenon occurs. The soundlevels associated with this tend to be very low, as only a small numberof cavitations of formed bubbles are present. As the power delivered viaactive conductor 200 is steadily increased, the rate of gas formationincreases, along with the rate of bubble collapse. Sound levels steadilyincrease until specific stoichiometric combinations of oxygen andhydrogen gases have been achieved and the oxy-hydro combustion chainreaction is initiated. As the rate of oxy-hydro combustion is furtherincreased, the combustion volume increases, as does its sound output. Atime sequence comparison of the sampled data can be run to determinetrend data for establishing a stable control variable. Such controloutput can be performed in the manner of ratio controlling 140 to“throttle” equipment output functions based on sensed/detectedparameters at the treatment site. Standard communications links 145 canbe used to interconnect adjunct equipment to the electrosurgicalcontroller or other ratio-controller that works in tandem with theelectrosurgical controller.

FIG. 9 depicts use of the alternative pH-sensing embodiment utilizingsingle wire ion-specific detector 420, which is accurately correlated toprobe power output and acid-base shift at the treatment site andcircuitry for governing electrosurgical processes. The ion specific pHwire sensor is, in one embodiment, made of an Mg—Ni metal alloy forsensing capacitive shift in the presence of Cl⁻ ions or similar metalalloy for sensing Na⁺ ions. As active electrode 150 is energized andcurrent flows to return electrode 170 the fundamental electrolysisreactions 10 take place, producing acid-base shifts in the media ormaterial immediately about the active electrode. Irrigation fluidelectrolyte 410 is drawn toward the active electrode as part of theconvective forces induced by normal heating of the active electrode 150.Flow is further induced by suction flow of acid-base pairs of higherdensity 430 flowing away from the active electrode due to gravitationalacceleration and convective forces. The conductor wire for the pH iondetector wire 250 delivers the capacitive shift data driven by thepresence of acid-base pairs at the sensor 420. This capacitive shift canbe converted at the electrosurgical controller to a digital signal viaA/D flip-flop for use in software driven algorithms.

FIG. 10 depicts use of thermo-luminescent crystal beacon element 440 toprovide visual feedback system to the practitioner for understandingtreatment site temperature. The crystal element includes europium dopedmagnesium bromide crystalline structures. The crystalline structure isoptionally stabilized for the electrosurgical environment, such as bymeans of an optically clear coating, for example a quartz silica glassor polymethylmethacrylate polymer. The thermo-luminescent crystal isdisposed on the distal portion of the insulating member in proximity ofthe active electrode 150. Proximity to active electrode 150 providesmeans to sense both contact conducted temperature of the actualtreatment site being affected by the energy flux completing the circuitbetween active electrode 150 and return electrode 170. This energy fluxis the source of energy that drives electrolysis equations 10 and, in sodoing, generates heat within the fluid surrounding the active electrode.The heat generated is both convectively and conductively transferredthrough the irrigant media, and convectively and conductively heatsinsulating member 450 with thermo-luminescent element 440 disposed atthe distal tip of the probe. As the thermo-luminescent element 440 isheated, molecular excitations cause electron orbital fluctuations andthe release of photons of known wavelength. As the light and color shiftof the crystal are correlated to its ambient temperature a direct visualaid is created that directly illustrates the temperature of theenergized probe. The practitioner can then respond immediately toluminescence shifts in thermo-luminescent element 440 to appropriatelymeter probe activation and treatment as well as power set points on theelectrosurgical controller.

FIG. 11 depicts use of thermo-electric semi-conductor 460 constructed ofbismuth-telluride. As the active electrode is activated, electrolysis isinitiated and dependent on total power input rates increase to theignition point of sustained oxy-hydro combustion. As the total powerinput is increased, localized heating of the conductive intermediaryagent, irrigant, or media is raised. The thermoelectric sensor developsintermolecular excitations from the increase in temperature andsubsequently conducts current at the electrons in the semi-conductortranslate, a technique familiar to those skilled in the art of Pelltiertype thermoelectric generators. The thermoelectrically generated currentis conducted along conductor 400 and is coupled to the electrosurgicalcontroller and can be used as disclosed above to perform both basic andadvanced control functions based on localized treatment sitetemperature. As should become evident to those skilled in the art, thethermoelectric sensor can easily be substituted with a piezo-electricthin-film pyrometer that functions in a similar manner to thebismuth-telluride semiconducting thermoelectric materials.

Accordingly, the use of methods and devices that allow sensing,detecting, measuring, and controlling relevant parameters ofelectrosurgery as described in this invention provide for new andunexpected advantages to the medical practitioner and patient inimproving electrosurgical treatments, providing better control ofelectrosurgical treatments, and improving overall efficaciousness ofelectrosurgical treatments, as depicted in FIG. 12. This occurs due toimproved understanding of physiochemical interactions which areaccurately controlled for such outcomes. For example, these sensing,measuring, and detecting methods and devices for electrosurgery allowfor the accurate therapeutic use of the electrolysis and oxy-hydrocombustion reactions during electrosurgery. This allows the practitionerto harness the electrolysis and/or the oxy-hydro combustion portions ofthe electrosurgical phenomenon designed for specific therapeuticinterventions by sensing, measuring, and detecting relevant parametersof electrosurgery. In one instance, for those procedures which rely uponthe electrolysis portion of the electrosurgical phenomenon alone, thedetermination of when oxy-hydro combustion is occurring is important sothat oxy-hydro combustion can be avoided in those settings. In anotherinstance, for those procedures which rely upon the oxy-hydro combustionportion of the electrosurgical phenomenon alone, the determination ofwhen electrolysis is occurring is important so that electrolysis can beavoided in those settings. In yet another instance, for those procedureswhich rely upon both the electrolysis and the oxy-hydro combustionportion of the electrosurgical phenomenon, the determination of wheneach reaction is occurring is important so they can be regulated inthose settings. These determinations can be via sensing, measuring, ordetecting temperature, pH, gas production, conductivity, ions, acousticparameters, and the like at the electrosurgical treatment site, whichoptionally are translated to visible or controller indication/feedbackof the actual probe system and treatment site occurrences. This enablesthe devices and instrumentation to self-regulate as to when it isappropriate to decrease or increase energy input or other localparameters, such as irrigants, temperature, acid-base flush, saltconcentration, and the like, so that the reactions can be moreaccurately controlled. Further, the practitioner will have additionalinformation regarding the specific treatment locale so that yet anotherlevel of control can be imposed upon the treatment venue.

Those skilled in the art will clearly see that controls for modernelectrosurgery should rely upon sensing electrosurgical physiochemistryto better inform practitioners of potential harmful effects ofelectrosurgical treatments that are not desired for a particulartherapeutic application. Furthermore, these methods and devices provideknowledge of the actual mechanisms at work in electrosurgery proceduresthat provide new paradigms for treatments heretofore unrecognized, tothereby enhance surgical outcomes.

The scope of the invention should be determined by the appended claimsand their legal equivalents, rather than by the examples given. Thepreceding examples can be repeated with similar success by substitutingthe generically or specifically described elements and/or operatingconditions of this invention for those used in the preceding examples.

Although the invention has been described in detail with particularreference to these preferred embodiments, other embodiments can achievethe same results. Variations and modifications of the present inventionwill be obvious to those skilled in the art and it is intended to coverin the appended claims all such modifications and equivalents. Theentire disclosures of all references, applications, patents, andpublications cited above are hereby incorporated by reference.

What is claimed is:
 1. An apparatus for electrosurgery, comprising: atleast one active electrode for inducing electrolysis in anelectrolyzable environment; and at least one detector proximal to the atleast one active electrode for detecting a parameter relating toelectrolysis.
 2. The apparatus of claim 1, wherein the detector detectspH concentration.
 3. The apparatus of claim 1, wherein the detectordetects conductivity.
 4. The apparatus of claim 1, wherein the detectordetects ion concentrations.
 5. The apparatus of claim 1, wherein thedetector detects gas production.
 6. The apparatus of claim 5, whereinthe detector detects gas production of oxygen or hydrogen.
 7. Theapparatus of claim 1, wherein the detector detects sound.
 8. Theapparatus of claim 7, wherein the detector detects sound at betweenabout 10 kHz and about 600 kHz.
 9. The apparatus of claim 1, wherein thedetector detects changes in local pressure.
 10. The apparatus of claim1, further comprising a return electrode.
 11. The apparatus of claim 10,wherein the detector is disposed between the at least one activeelectrode and the return electrode.
 12. The apparatus of claim 1,further comprising a detection circuit for receiving a parameterdetected by the detector.
 13. The apparatus of claim 12, furthercomprising a control circuit providing an output control signalcontrolling an amount of power output to the at least one activeelectrode in response to an output from the detection circuit.
 14. Theapparatus of claim 1, wherein there are at least two active electrodes.15. The apparatus of claim 1, further comprising a probe body with adistal end and a proximal end, with at least one active electrodedisposed on the distal end.
 16. The apparatus of claim 15, wherein theat least one detector proximal to the at least one active electrode islocated on the probe body.
 17. The apparatus of claim 16, wherein the atleast one detector proximal to the at least one active electrode islocated within the probe body.
 18. The apparatus of claim 17, whereinthe at least one detector proximal to the at least one active electrodeis located in front of the at least one active electrode.
 19. A methodof performing electrolytic electrosurgery on a patient, the methodcomprising: providing a probe having at least one active electrode forinducing electrolysis in an electrolyzable media; providing at least onedetector proximal to the at least one active electrode for detecting aparameter relating to electrolysis; introducing an electrolyzable mediato an anatomical part of the patient; positioning the active electrodewithin the electrolyzable media adjacent the anatomical part of thepatient; providing a form of electrical power to the active electrode;and adjusting at least one operational factor of the probe in responseto the parameter detected by the at least one detector.
 20. An apparatusfor electrosurgery, comprising: a probe with a distal end and a proximalend, with at least one active electrode and at least one returnelectrode disposed on the distal end, the proximal end forming a handlefor holding the probe; a cylindrical insulating sleeve positioned aroundthe distal end of the probe; an adjustably positionable actuatordisposed on the handle and translatably connected to the cylindricalinsulating sleeve, such that the cylindrical insulating sleeve can belongitudinally translated relative to the distal end of the probe,thereby forming a cavity of variable volume about the distal end of theprobe; and at least one detector proximal on the distal end of the probeand within the cavity of variable volume for detecting a parameterrelating to electrolysis or oxy-hydro combustion.